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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.

Warning: Do not use with Carmustine or Thiotepa

The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:

• Ambidextrous with beaded cuff and straight fingers
• Finger-textured,
• Blue colored
• Containing Hyaluronic Acid coating.
• Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
• Tested against chemotherapy drugs and fentanyl citrate.

The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) summary for a medical device (nitrile patient examination gloves with hyaluronic acid) and details the performance testing against established standards.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document includes a "Technological Characteristics Comparison Table" (pages 7-9) that serves this purpose. It compares the applicant's device to a predicate device (K200671). The "Acceptance Criteria" column effectively outlines the criteria, and the "Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves..." column shows the reported device performance.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the test sets in the non-clinical tests (e.g., how many gloves were tested for pinholes, how many animals were used for biocompatibility testing). However, it refers to industry standards like ASTM and ISO, which typically define appropriate sample sizes for such tests.

• Provenance: The tests were performed in accordance with international standards (ASTM, ISO). The manufacturing company is Anhui Intco Medical Products Co., Ltd. located in Anhui, China. The testing itself is presented as non-clinical testing to demonstrate performance against these standards. The testing format suggests a retrospective evaluation against pre-defined performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the document describes performance testing of physical characteristics of gloves against codified standards (ASTM, ISO), not an AI device or a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the pass/fail criteria defined by the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as the document describes performance testing of physical characteristics against codified standards. There is no subjective adjudication process for the test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance tests conducted (e.g., tensile strength, pinholes, chemical permeation, biocompatibility) is established by industry standards and test methods (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05, ISO 10993 series). These standards define the acceptable range or threshold for a given characteristic to be considered compliant.

8. The sample size for the training set:

This is not applicable. The device is a medical glove, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable.

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Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided documentation describes the non-clinical performance testing of a medical device, specifically Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598). The study aims to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K223713).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by various ASTM and ISO standards, and the reported performance indicates that the device passed these criteria. The key performance metrics are related to physical dimensions, physical properties (tensile strength, elongation), freedom from holes, residual powder, permeation by chemotherapy drugs and fentanyl citrate, and biocompatibility.

Important Note on Chemotherapy Drugs: The document explicitly states: "Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa: 0 minute. Warning: Do not use with Carmustine and Thiotepa." This means that while the glove was tested against these drugs, its performance for them is below the typical acceptable threshold for chemotherapy gloves (which is usually >240 minutes for other drugs), and this is a critical aspect of its labeling and intended use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) used for each performance test. It only refers to the standards (e.g., ASTM D6319-19, ASTM D6978-05), which would specify the required sample sizes for testing. For instance, ASTM D6319-19 defines AQL (Acceptable Quality Level) for certain tests (e.g., G-I, AQL 2.5 for water leak test), which implies specific sampling plans.
• Data Provenance: The tests were non-clinical performance studies. The data provenance is linked to the manufacturer, Anhui Intco Medical Products Co., Ltd., China. The tests are described as having been "conducted to verify that the proposed device met all design specifications," implying a prospective testing approach within a laboratory setting, rather than retrospective analysis of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The "ground truth" for glove performance (e.g., tensile strength, breakthrough time, freedom from holes) is established through standardized laboratory testing methods (ASTM, ISO), not through expert consensus or clinical judgment of images or patient data. The results are objective, measurable physical properties and chemical resistance.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation, where human readers might disagree, and a consensus or majority opinion is needed to establish ground truth. For the physical and chemical performance tests of gloves, the results are quantitative and objective, determined by laboratory equipment and standardized procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, a physical barrier, not a diagnostic tool requiring human interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and chemical resistance of the glove itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Standardized Measurement: Directly measurable physical properties (e.g., length, width, thickness, tensile strength, elongation, residual powder).
• Controlled Chemical Permeation Tests: Breakthrough detection times for specific hazardous chemicals (chemotherapy drugs, fentanyl citrate).
• Biological Testing: In-vivo (animal) and in-vitro tests for biocompatibility (skin irritation, sensitization, acute systemic toxicity) as defined by ISO standards.

Essentially, the "ground truth" is defined by the established and validated protocols of the cited ASTM and ISO standards for testing medical gloves.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (a glove) that undergoes manufacturing processes and performance testing, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of device.

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